Neuralink, the neurotech startup co-founded by Elon Musk, announced that it had received approval from the US Food and Drug Administration to start its first in-human clinical studies.
Neuralink, the brain-implant company co-founded by Elon Musk, announced on Thursday that it had received approval from the US Food and Drug Administration (FDA) for its first in-human clinical trial.
Musk's Neuralink aims to enhance people's vision and mobility by establishing a direct connection between the human brain and computers. While Neuralink has clarified that it currently doesn't have plans to begin participant recruitment immediately, obtaining FDA approval represents a significant milestone for the company as it comes after facing previous challenges in obtaining clearance.
Since its establishment in 2016, the company, co-founded by Mr. Musk, has consistently overestimated the pace at which it can execute its plans. Originally, Neuralink set a goal to begin implanting chips in human brains by 2020. However, the timeline was later revised to aim for a start in 2022.
The business faced another setback in December of the previous year when it reportedly faced an investigation for alleged animal welfare violations related to its work. Earlier, the company had denied similar allegations.
According to a March report from Reuters, which cited several current and former employees, Neuralink previously also attempted to secure FDA approval, although it was rejected due to safety concerns.
Neuralink aims to utilize its microchips for the treatment of conditions such as paralysis, blindness, obesity, autism, depression, and schizophrenia and to enable individuals with disabilities to effectively utilize computers and mobile technology. These chips, which have undergone testing in monkeys, are designed to interpret brain signals and transmit information to devices via Bluetooth.
In a Twitter announcement, Neuralink described Thursday's news as an "important first step" in helping numerous people with their technology in the future. The company acknowledged that FDA approval was achieved through the "incredible work by the Neuralink team in close collaboration with the FDA."
Neuralink also pledged to share further details regarding its plans to recruit participants for clinical trials in the near future.
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